Biological, Physical and Chemical Testing

A medical device or material used in a medical device that comes in direct contact with a patient must be able to perform its intended function without inducing significant rejection or adverse reaction in a patient. The degradation or leaching of chemicals and other device materials may lead to deleterious effects on a patient, and potential adverse reactions can range from the rejection of the device by the body to longer term reproductive or developmental effects.

For these reasons, medical devices and materials are typically subject to a range of biological, physical and chemical tests to ensure that the benefits offered by the device exceed any potential risks to a patient as a result of the device itself or the materials used in the device.

The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.

Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.

Biological evaluations address a device’s biocompatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.

TÜV SÜD laboratories offer a comprehensive range of chemical, physical and biological testing services in accordance with applicable international standards. In addition, TÜV SÜD Product Service’s industry specialists and clinical practitioners have extensive experience with all types of medical devices.

FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.

The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.

Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.

Biological evaluations address a device’s biocompatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.

Why choose TÜV SÜD

TÜV SÜD laboratories offer a comprehensive range of chemical, physical and biological testing services in accordance with applicable international standards. In addition, TÜV SÜD Product Service’s industry specialists and clinical practitioners have extensive experience with all types of medical devices.

FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.

Your benefits at a glance

Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.

Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD Product Service conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.

Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.

Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.